NCT05766163

Brief Summary

The object of this exploratory clinical trial is to evaluate post-operative complications in a population that underwent Robotic Assisted Radical Prostatectomy (RARP) made with multiple platforms:

  • DaVinci;
  • Hugo;
  • Versius. The questions it aims to answer are:
  • Does the estimation of the post-operative complications suggest something?
  • Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable? Participants will be invited to fill out questionnaires and join one of these three groups:
  • surgery with the daVinci platform;
  • surgery with the Hugo platform;
  • surgery with the Versius platform.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

February 13, 2023

Last Update Submit

April 11, 2023

Conditions

Prostate Cancer

Keywords

Robotic-assisted surgeryProstatectomyMultiple surgical platformsPostoperative complicationsOperative outcomes

Outcome Measures

Primary Outcomes (3)

  • Number of participants with postoperative complications

    Overall postoperative complications (% score \>0) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

    Over the 4 days post surgery

  • Number of participants with moderate to major postoperative complications

    Moderate to major complications (% score \>=2) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

    Over the 4 days post surgery

  • Number of participants with major postoperative complications

    Major complications (% score \>=3) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

    Over the 4 days post surgery

Secondary Outcomes (14)

  • Estimated Blood Loss

    Intraoperative

  • Overall duration of the surgery

    Intraoperative

  • Anesthesia, Lymphadenectomy, Prostatectomy

    Entrance of patient into operating room until completion of surgery

  • Number and type of intraoperative complications

    Intraoperative

  • Postoperative hospitalization

    From the surgery day up to 10 days postoperative

  • +9 more secondary outcomes

Study Arms (3)

DaVinci system

ACTIVE COMPARATOR

Robot-assisted radical prostatectomy is carried out through daVinci platform.

Device: DaVinci RARP

Hugo system

EXPERIMENTAL

Robot-assisted radical prostatectomy is carried out through Hugo platform.

Device: Hugo RARP

Versius system

EXPERIMENTAL

Robot-assisted radical prostatectomy is carried out through Versius platform.

Device: Versius RARP

Interventions

DaVinci RARPDEVICE

Assisted-robotic radical prostatectomy.

Also known as: DaVinci® Surgical System
DaVinci system
Hugo RARPDEVICE

Assisted-robotic radical prostatectomy.

Also known as: Hugo™ RAS System
Hugo system
Versius RARPDEVICE

Assisted-robotic radical prostatectomy.

Also known as: Versius® Robotic Surgery System
Versius system

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 and \< 90 years;
  • Organ-localized prostate cancer with a surgical indication of radical prostatectomy;
  • Informed consent provided.

You may not qualify if:

  • Age \< 18 and \> 90 years;
  • Contraindication to radical prostatectomy procedure;
  • Non-organ confined prostate cancer;
  • Refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Unit, AOUI Verona

Verona, 37126, Italy

RECRUITING

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsPostoperative Complications

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alessandro AA Antonelli

    Azienda Ospedaliera Universitaria Integrata Verona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro AA Antonelli

CONTACT

+39 0458127701alessandro.antonelli@aovr.veneto.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Urology Unit

Study Record Dates

First Submitted

February 13, 2023

First Posted

March 13, 2023

Study Start

March 14, 2023

Primary Completion

March 1, 2024

Study Completion

September 1, 2024

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)